MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE DEVICE

Model Number S606

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the battery of this implantable pacemaker was less than nine months and for about 1.5 years.Boston scientific technical services (ts) discussed that this device longevity remaining first displayed from greater than five years in less than 0.5 years in 0.5 year increments so nine months is not possible.Ts also discussed battery management for this device that utilize current bins and this is likely a scenario where the device when from a higher current bin to a lower one giving an increase in longevity.This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that battery status indicators were different than expected based on information provided to boston scientific.Factors influencing the estimated longevity remaining calculation include pacing rate, amplitude, pulse-width and lead impedance.Any (even slight) changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please refer to the b5: describe event or problem for more information regarding the specific circumstances of this event.Please note this pacemaker's battery was designed to estimate remaining longevity (and trigger corresponding device replacement indicators) based on the pacing capacitor charge time, which progressively increases as the battery depletes.These pacemakers were not designed with an ability to calculate remaining longevity for every possible current drain, which may cause replacement indicators to trigger earlier than what was previously estimated; however, it does not negatively impact the use, operation, safety, or performance of the device.

Event Description

It was reported that the battery of this implantable pacemaker was less than nine months and for about 1.5 years.Boston scientific technical services (ts) discussed that this device longevity remaining first displayed from greater than five years in less than 0.5 years in 0.5 year increments so nine months is not possible.Ts also discussed battery management for this device that utilize current bins and this is likely a scenario where the device when from a higher current bin to a lower one giving an increase in longevity.This device remains in service.No adverse patient effects were reported.

• Brand Name: ALTRUA 60
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19052228
• MDR Text Key: 339878503
• Report Number: 2124215-2024-20834
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: 00802526484490
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2012
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 139896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male